Let’s build on our FSMA tip of the week series by beginning with a quick review. We have previously highlighted the following requirements contained in Current Good Manufacturing Practice, Hazard Analysis and Risk Base Preventive Controls for Human Food:
- Hazard analysis must be documented regardless of outcome
- Hazard evaluation (site-specific) must consider the food safety effect on finished product due to formulation, condition, function of building/equipment design, raw materials, transportation, processing, packaging, labeling activities, storage/distribution, intended use, sanitation/employee hygiene, and weather-related factors
- Having additional hazard analysis documentation from many sources (Reportable Food Registry recall analysis, regulatory guidance, scientific studies, illness data/Centers for Disease Control, process authorities/technical experts, trade associations supporting, plant/supplier food safety history, etc.) to support your conclusions and decision making on what preventive controls are necessary to produce safe food
- For Ready-to-Eat (RTE) products, a hazard evaluation for environmental pathogens must be done whenever products are exposed to the environment prior to packaging if a formulation or additional control measure is not in place to significantly minimize the identified pathogen
Remembering that approximately 90% of recalls are caused by undeclared allergens, Salmonella, and Listeria monocytogenes, let’s identify preventive controls that would have severe health consequences if effective preventive controls were not in place. These are generic examples and are not meant to be specific requirements for all food commodities or sectors.
Accurate allergen labeling for finished product and the appropriate use of those labels that prevent undeclared allergens are preventive controls. Labels, whether internally generated or purchased, should be confirmed as correct to ensure all allergens are declared. If you are purchasing packaging materials the ingredient statement and allergen declaration would likely be reviewed upon receipt to confirm that the label is correct and that the correct label was used when that product was being packaged.
If you are a processor using multiple allergens that are not contained in all products made on shared equipment, your preventive controls will prevent cross-contact per the requirements of Part 117 Subpart B, Current Good Manufacturing Practice. This will include preventive control measures through production scheduling, equipment cleaning, managing rework, and preventing in-process and post-process allergen cross-contact (personnel/operational practices and separation of processes). Additional cross-contact preventive controls not typically monitored on a day-to-day basis include sanitary design, supplier allergen ingredient controls, and validation of preventive controls.
Your environmental hazard evaluation for RTE product will dictate the rigor of your environmental testing program. Considerations include: effects on finished product due to formulation, condition, function of building/equipment design, raw materials, transportation, processing, packaging, labeling, storage/distribution, intended use, sanitation/employee hygiene, and weather-related factors. Your environmental testing program will actively seek out pathogen harborage points, and investigate the source and causative factors to prevent cross-contact.
If you have a process kill step that controls an identified pathogen, that is a preventive control. These preventive controls would be monitored per the requirements of the preventive control rule if it were not already being monitored as a CCP under the HACCP program.
Hopefully these examples will help with your thought process when considering the preventive controls you need to prevent consumer health consequences and avoid a costly recall.